ARTICLE SUMMARY:
In this week’s Pathways Picks: Industry groups explain why tariffs are counterproductive and propose a streamlined regulatory/reimbursement path tied to domestic operations; US and European physician groups engage on AI; Europe finalizes EU-wide HTA rules for devices; CMS recalls staff; India software guidance; South Korea streamlines manufacturing reviews, and more from the UK, Europe, and Brazil.
Tariff Pushback and Proposals
Medtech groups detail opposition to tariffs and propose alternative steps:
Commerce gets an earful. The US Department of Commerce received 816 public comment letters by the deadline it set for last Friday to inform its ongoing “Section 232” investigation of the national security implications of medical device and personal protective equipment imports. The department has yet to publicly release the full docket of letters, but AdvaMed, the Medical Device Manufacturers Association, and the Business Roundtable were among the respondents that pushed hard against the prospect of medtech sector-specific tariffs. The administration has leveraged the Section 232 authority to implement new tariffs, on top of Trump’s broader tariff regime, targeting multiple industries including pharmaceuticals, a fate device companies hope to avoid. The groups used the opportunity to spotlight medtech as an economic powerhouse. “The US medtech manufacturing footprint is a strategic asset that drives approximately $75 billion in exports annually, supporting an estimated 160,000 jobs directly,” AdvaMed CEO Scott Whitaker wrote in the association’s comments.
